FDA.reportPublic FDA data

TintoAutomation Cleaner

Primary DI
B502BSB70630
Brand
TintoAutomation Cleaner
Company
BIO SB, INC.
Model
BSB 7063
Catalog number
BSB 7063
Device description
The TintoAutomation Cleaner is a 3-component cleaning solution for removal of DAB chromogen stains and precipitates from the TintoStainer Plus automated platform, glassware, labware, or other surfaces that come in contact with DAB.
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B502BSB70630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)561-1145sales@biosb.com

Regulatory Flags#

DUNS number
102855447
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B502BSB52580CD45RA (4KB5) MMabConcentrate, 1 mlBSB 52582020-03-16
B502BSB74000TintoStainer Plus Automated SystemBSB-7400BSB-74002025-03-28
B502BSB7400100TintoStainer Plus Automated System MiniBSB-7400-10BSB-7400-102025-03-28
B502BSB7400600TintoStainer Plus Automated System LXBSB-7400-60BSB-7400-602025-03-28
B502BSB9420CS0Tryptase Control SlidesBSB-9420-CSBSB-9420-CS2025-03-28
B502BSB02010Mouse/Rabbit PolyDetector DAB HRP BrownBSB 0201BSB 02012025-03-18
B502BSB0307CS05-Core Multi-Infectious Disease Cell Line Microarray Control SlidesBSB-0307-CSBSB-0307-CS2025-03-18
B502BSB0307S0Mohs Mouse/Rabbit PolyDetector DAB HRP BrownBSB 0307SBSB 0307S2025-03-18
B502BSB0308CS02-Core SV-40 Cell Line Microarray Control SlidesBSB-0308-CSBSB-0308-CS2025-03-18
B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBSB-0309-CSBSB-0309-CS2025-03-18
B502BSB0310CS02-Core Adenovirus Cell Line Microarray Control SlidesBSB-0310-CSBSB-0310-CS2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBSB-0333-CSBSB-0333-CS2025-03-18
B502BSB0352150PIN MultiDetector (CK 34BE12, p63 & AMACR)BSB-0352-15BSB-0352-152025-03-18
B502BSB0352500PIN MultiDetector (CK 34BE12, p63 & AMACR)BSB-0352-50BSB-0352-502025-03-18
B502BSB0353500PNI Carcinoma MultiDetector (CK 5 & 6 Cocktail & NGFR)BSB-0353-50BSB-0353-502025-03-18
B502BSB03551000Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-100BSB-0355-1002025-03-18
B502BSB0355150Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-15BSB-0355-152025-03-18
B502BSB035550Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-5BSB-0355-52025-03-18
B502BSB0355500Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-50BSB-0355-502025-03-18
B502BSB03561000Mohs Mouse/Rabbit PolyDetector Plus HRP GreenBSB-0356-100BSB-0356-1002025-03-18

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04250317510174TubeChromsystems Instruments + Chemicals GmbHLXG2025-07-31
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